Stress Reduction in Middle Eastern Refugees

Phase 2

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Behavioral: Narrative Exposure Therapy

• Registration Number: NCT01288690
• Lead Sponsor: Wayne State University

Brief Summary

This interventional, randomized controlled study tests the effects of a a brief psychological intervention (Narrative Exposure Therapy) against a wait list control group among refugees who have experienced trauma and have some symptoms of PTSD.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-13
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Refugees from the Middle East, and possible from Africa, who have experienced conflict-related trauma, have symptoms of PTSD, and speak either Arabic or English

Exclusion Criteria

• Currently received exposure therapy for PTSD
• Planning to leave area in next 4 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narrative Exposure Therapy	Narrative Exposure Therapy	Patients in this condition receive 3 sessions of Narrative Exposure Therapy

Primary Outcome Measures

Name	Time	Method
Post traumatic stress disorder symptoms: Harvard Trauma Questionnaire	Baseline to 4 months.	The number and severity of post traumatic stress disorder symptoms will be assessed using an Arabic adaptation of the Harvard Trauma Questionnaire.; The Harvard Trauma Questionnaire will be administered at baseline prior to randomization and 4 months from baseline (about three months from last intervention session). Questions assess symptoms over the preceding one week.

Secondary Outcome Measures

Name	Time	Method
Physical symptoms: Patient Health Questionnaire	Baseline to 4 months	Physical symptoms will be assessed using an Arabic translation of the Patient Health Questionnaire at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). Questions assess symptoms over the preceding 4 weeks.
Depression symptoms: Beck Depression Inventory II	Baseline to 4 months.	Depression symptoms will be assessed using an Arabic translation of the Beck Depression Inventory II. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions assess symptoms over the preceding two weeks.
Quality of sleep: Karolinska Institute Sleep Questionnaire	Baseline to 4 months	Quality of sleep will be assessed using an Arabic translation of five items from the Karolinska Institute Sleep Questionnaire. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions don't specify a time frame for the symptoms.
Daily functioning	Baseline to 4 months	Daily functioning is assessed using 8 items developed by the Primary Investigator in collaboration with other colleagues. The items assess areas such as spending time with family and friends, utilizing health, immigration, language, and employment services, and participating in religious and social activities. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session).The questions assess functioning over the preceding 4 weeks.
Post traumatic growth: Post Traumatic Growth Inventory	Baseline to 4 months	Positive and growth outcomes sometimes experienced by people who have experienced traumatic events will be assessed using an Arabic translation of the Post Traumatic Growth Inventory. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions do not specify a time frame.
General Psychological Well-being: WHO Well-being Index	Baseline to 4 months	Markers of mental well-being such as positive mood, vitality and interest will be assessed using the Arabic version of the World Health Organization's Well-being Index. The scale will be administered at baseline prior to randomization, and 4 months from baseline (about three months from last intervention session). The questions assess functioning in the preceding two weeks.

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States